Bioanalysis and bioanalytical method validation are integral aspects of any preclinical and clinical research program. Organizations developing potentially life-changing therapeutics need to be able to carefully measure key biomarkers from clinical samples to help determine efficacy and safety on a molecular level, in addition to assessments of clinical outcomes. Done properly, bioanalytical method development empowers clinical research with approaches that precisely and accurately track both drug levels and patient response to therapy. In turn, this fortifies the clinical trial through the collection of data at the center of the drug’s behavior and mechanism of action.
Despite its central nature in clinical research, the sheer diversity of potential biomarkers, novel drugs, biological matrices, methodologies, and analyses can complicate bioanalysis and biomarker testing. With so many aspects to consider and evaluate, it can be a challenge to find, optimize, and execute the approach best suited for your clinical bioanalysis needs. This is especially true for companies that lack the necessary equipment and infrastructure.
Biomarker Classes & Categories
Clinical researchers need data they can rely on. To achieve this, companies need to be confident that both bioanalytical method development and its execution are handled with the skill, care, and know-how of experienced bioanalysis experts, armed with the right instrumentation.
This is where Avomeen can make an impact for our partners.
Avomeen’s purpose-built bioanalysis and clinical biomarker services help our partners readily detect and measure relevant biomarkers, understand drug performance, and provide clinical trial support. Our team maintains both an up-to-date knowledge of the bioanalytics landscape and the advanced instrumentation required to skillfully handle any bioanalysis request: from bioanalytical method development to clinical execution and everything in between. With decades of experience in both analytical chemistry and biology, Avomeen understands what it takes to construct a method that clearly separates analytes of interest for accurate quantification in the full context of biological systems. As true partners, Avomeen can then act as your bioanalytical laboratory, performing data collection and analysis as needed, with fast turnaround times and a commitment to quality.
Partner with Avomeen to:
- Develop, validate, and transfer both existing and custom assays for novel biomarkers and therapies
- Transfer existing assays to alternative analytical platforms
- Maximize analytical platforms including ddPCR, immunoassays, and LC-MS bioanalysis (Orbitrap QExactive and other systems)
- Use NMR to help identify completely novel biomarkers
- Increase sensitivity and determine ppb/ppt limit of detection (LOD)
- Develop and work with both single-plex and multi-plex assays
- Execute high throughput testing of clinical samples
Bioanalytical Method Development, Validation, and Transfer
Whether you’re working with a well-established biomarker or a novel one, Avomeen’s biomarker services can support all aspects of bioanalytical method development and validation, through to clinical trial support.
Biomarker Validation Process
If you have a method in place, Avomeen’s team can work closely with your own to increase method efficiency, robustness, sensitivity, selectivity, and ease of use, while identifying potential liabilities and de-risking regulated issues. Alternatively, our bioanalytical laboratory can design custom methods and assays for well-known and obscure biomarkers alike, developing them under the strict quality controls required by regulatory bodies (like the FDA and EMEA) and standards, including ISO, GLP, and GMP guidelines. Given the high-stakes environment of clinical research and regulatory approval, quality control is embedded into all of our clinical biomarker services, from beginning to end.
Bioanalytical method validation also requires a detailed appreciation for the complexities associated with patient samples, such as diverse molecular composition and sample variations found across a cohort. Building on past experience, Avomeen’s clinical biomarker services team is also adept with sample collection, stabilization, and extraction techniques. Each of these approaches are specifically optimized for individual biological matrices, biomarkers, and drugs, collectively circumventing common challenges associated with using a bioanalytical assay on patient samples.
And then there’s tech transfer. We recognize the frustration associated with difficult method transfer processes. Taking this essential task seriously, Avomeen considers effective method transfer as an essential component for making our work actionable. Our team works diligently to ensure information is properly transferred for the long-term success of your project.
High Throughput Bioanalysis
In addition to custom biomarker assay services and bioanalytical method validation, Avomeen can apply a previously established method, or one we’ve developed, to execute sample analysis for both preclinical and clinical research.
We understand that scientific teams sometimes don’t have the bandwidth to manage an influx of sample bioanalysis – in addition to their existing responsibilities. To support your work without sacrificing precious time, Avomeen’s bioanalytical laboratory can act as an extension of your team, applying their world-class expertise to quickly and carefully analyze your samples using your preferred method.
Avomeen’s bioanalytical lab can use your existing methods or develop new ones to perform experimentation for a variety of drug and biomarker studies. Clients may also access off-the-shelf solutions for dosing formulation analysis, quantitative analysis of biomarkers and drugs in biological matrices, and interference testing, as well as toxicity and clearance. As a result, Avomeen can perform a number of analyses out the gate without sacrificing data quality, offering tremendous benefits in terms of turnaround times.